Morbid obesity remains an ever-growing problem in the U.S. Varying forms of gastric bypass surgery have developed and have improved over the last few decades. Recently, laparoscopic gastric banding has emerged as a less invasive surgical option. However, bariatric surgery is fraught with morbidity of up to 20%, with a re-operation rate approaching 25% at 3-5 years post-op. Bariatric surgery carries an operative mortality of 0.5%. Diet and pharmaceutical alternatives have not been very effective, with a high recidivism rate. Today, the Bioenterics® intragastric balloon (BIB®) (Inamed Corporation, Santa Barbara, Calif., USA) is in use outside of the U.S., achieving average weight loss of 15 kg and 5 point drop in BMI. However, an 8-9% balloon deflation rate has resulted in unwarranted migration leading to obstruction.
PCT Patent Publication WO 06/070361 to Brooks, which is incorporated herein by reference, describes apparatus for use in a gastrointestinal tract of a subject. The apparatus includes a straightening rod, and a flexible tubular anchor having a distal end and an open proximal end, and sized to fit in the gastrointestinal tract. The anchor comprises a material that has an elastic memory which biases the anchor towards assuming a pre-selected bent configuration. The anchor is shaped so as to define a central core extending from the open proximal end toward the distal end. The anchor is configured to be straightened from the pre-selected bent configuration by insertion of the straightening rod in the central core. The apparatus further includes a device coupled to the anchor, selected from the list consisting of: a therapeutic device, and a transmitting device.
US Patent Application Publication 2004/0044357 to Gannoe et al., which is incorporated herein by reference, describes gastric space occupying devices that include a stent configured for deployment in the gastrointestinal tract of a patient, and in particular, for deployment in the esophagus or the stomach. Secured to the stent is an expandable member that is adapted to reside within the patient's stomach. When expanded, the expandable member occupies a predefined volume within the patient's stomach and is further tethered to the deployed stent, thereby retaining or anchoring the expandable member within the stomach. Methods and systems for the deploying the space occupying devices are also described.
PCT Publication WO 05/107641, US Patent Application Publication 2005/0267596, and US Patent Application Publication 2005/0267595 to Chen et al., which are incorporated herein by reference, describe a gastric balloon that includes a scaffold structure, one or more internal inflatable compartments within the scaffold structure, and one or more inflatable bladders formed over the space-filling compartment. The gastric balloon may be deployed transesophageally using a gastroscope, and is inflated in situ, preferably using a combination of liquid and gas inflation media.
PCT Publication WO 05/009288 and US Patent Application Publication 2005/0033331 to Burnett et al., which are incorporated herein by reference, describe techniques for facilitating intermittent and/or partial obstruction of a pyloric valve. Devices described generally include a support portion for preventing the device from passing through the pyloric valve, and a tissue engagement portion for contacting tissue adjacent the pyloric valve to obstruct the valve. Some embodiments also include a positioning member extending from the tissue engagement portion for helping position the device for obstructing the valve. A retaining member may optionally be included on the distal end of the positioning member for further maintaining a position of the device in the stomach. Some embodiments are deliverable into the stomach through the esophagus, either by swallowing or through a delivery tube or catheter. Some embodiments are described as being fully reversible. Some embodiments self-expand within the stomach, while others are inflated or otherwise expanded.
US Patent Application Publication 2005/0055039 to Burnett et al., which is incorporated herein by reference, describes a device for performing one or more functions in a gastrointestinal tract of a patient, which includes an anchoring member and at least one actuator, sensor, or combination of both coupled with the anchoring device. The anchoring device is adapted to maintain at least part of the device within a pyloric portion of the patient's stomach and to intermittently engage, without directly attaching to, stomach tissue. Actuators perform any suitable function, such as transmitting energy to tissue, acting as a sleeve to reduce nutrient absorption, occupying space in the stomach, eluting a drug and/or the like. Sensors may be adapted to sense any suitable patient characteristic within the patient's gastrointestinal tract, such as pH, temperature, bile content, nutrient content, fats, sugars, alcohol, opiates, drugs, analytes, electrolytes and/or hemoglobin.
US Patent Application Publication 2006/0020278 to Burnett et al., which is incorporated herein by reference, describes methods, devices and systems which facilitate gastric retention of a variety of therapeutic devices. Devices generally include a support portion for preventing the device from passing through the pyloric valve or esophagus. A retaining member may optionally be included on the distal end of the positioning member and is described to maintain a position of the device in the stomach. Some embodiments are deliverable into the stomach through the esophagus, either by swallowing or through a delivery tube or catheter. Some embodiments are fully reversible. Some embodiments self-expand within the stomach, while others are inflated or otherwise expanded.
PCT Publication WO 05/094257 to Birk, which is incorporated herein by reference, describes a gastric balloon and method of adding and removing fluid therefrom. The gastric balloon includes a shell, a receiver, and a retractable tubing housed in the receiver and extendable from the stomach of a patient to the mouth of the patient. The shell is inflated and deflated from outside the body of the patient. The method of adding or removing fluid from the implanted gastric balloon includes steps of inserting a gastroscopic tool into the stomach of a patient and grasping an end of a retractable tubing housed in a receiver of the gastric balloon. Further steps of the method include withdrawing at least a portion of the retractable tubing from the stomach and out of a patient's mouth and adding or removing fluid from the gastric balloon via the retractable tubing withdrawn from the patient.
The following patents and patent application publications, which are incorporated herein by reference, may be of interest:
U.S. Pat. No. 7,033,384 to Gannoe, et al.
US Patent Application Publication 2006/0190019 to Gannoe et al.
US Patent Application Publication 2002/0055757 to Torre et al.
US Patent Application Publication 2005/0228504 to Demarais
US Patent Application Publication 2005/0085923 to Levine et al.
US Patent Application Publication 2005/0192614 to Binmoeller
US Patent Application Publication 2004/0267378 to Gazi et al.
U.S. Pat. No. 4,416,267 to Garren et al.
U.S. Pat. No. 4,925,446 to Garay et al.
U.S. Pat. No. 5,052,998 to Zimmon
PCT Publication WO 05/039457 to Paganon et al.
PCT Publication WO 04/089262 to Paganon
Canadian Patent Application Publication 2483335 to Byrum et al.
US Patent Application Publication 2005/0070937 to Jambor et al.
US Patent Application Publication 2005/004430 to Lee et al.
PCT Publication WO 04/105622 to Ritchie
US Patent Application Publication 2004/088008 to Gannoe et al.
PCT Publication WO 04/014237 to Gannoe et al.
US Patent Application Publication 2004/093091 to Gannoe et al.
US Patent Application Publication 2004/059289 to Garza et al.
PCT Publication WO 03/095015 to Alverdy
European Patent Application Publication EP 1342458 to Creusy et al.
US Patent Application Publication 2003/158569 to Wazne
PCT Publication WO 03/055420 to Lointier et al.
U.S. Pat. No. 6,656,194 to Gannoe et al.
US Patent Application Publication 2003/171768 to McGhan
PCT Publication WO 02/40081 to Bales et al.
PCT Publication WO 01/66166 to Birk
PCT Publication WO 98/56321 to Pier et al.
U.S. Pat. No. 5,234,454 to Bangs
Canadian Patent Application Publication CA 2068715 to Kuzmak
U.S. Pat. No. 4,696,288 to Kuzmak et al.
U.S. Pat. No. 5,129,915 to Cantenys
U.S. Pat. No. 5,084,061 to Gau et al.
U.S. Pat. No. 4,908,011 to Jacobsen et al.
European Patent Application Publication EP 0246999 to Eshel et al.
PCT Publication WO 87/00034 to Taylor
U.S. Pat. No. 4,739,758 to Lai et al.
PCT Publication WO 86/06611 to Kullas et al.
U.S. Pat. No. 4,694,827 to Weiner et al.
German Patent Application Publication DE 3540936 to Stricker et al.
British Patent Application Publication GB 2139902 to Celestin et al.
Canadian Patent Application Publication CA 1233387 to Garren et al.
U.S. Pat. No. 4,899,747 to Garren et al.
German Patent Application Publication DE 3326061 to Woerner
German Patent Application Publication DE 3310234 to Husfeldt
Italian Patent IT 1235492 to Frimberger et al.
U.S. Pat. No. 4,485,805 to Foster
German Patent Application Publication DE 3227585 to Woerner
U.S. Pat. No. 4,416,267 to Garren et al.
U.S. Pat. No. 4,315,509 to Smit
U.S. Pat. No. 7,004,176 to Lau
The following articles, which are incorporated herein by reference, may be of interest:
Kadakia S C et al., “Esophageal dilation with polyvinyl bougies using a marked guidewire without the aid of fluoroscopy,” Am J Gastro 88:1381-86 (1993)
Fleischer D E et al., “A marked guidewire facilitates esophageal dilation,” Am J Gastro 84:359-61 (1989)
Dumon J R et al., “A new method of esophageal dilation using Savary-Gilliard bougies,” Gastro Endosc 31:379-82 (1985)
Werth et al., “A safe and quick method for endoscopic retrieval of multiple gastric foreign bodies using a protective sheath,” Surg Gynecol Obstet 171(5):419-20 (1990)